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FDA advisors back GSK's lupus drug

Advisors to the US Food and Drug Administration have recommended the agency approve a lupus treatment developed by HGS and the GSK

A panel of advisors to the US Food and Drug Administration (FDA) has recommended that the agency grant marketing approval for a lupus treatment developed through a partnership between Human Genome Sciences (HGS) and GlaxoSmithKline (GSK), but raised a number of concerns about the drug that could ultimately affect its performance in the marketplace.

At a daylong meeting on Tuesday, the FDA's Arthritis Advisory Committee voted 13 to two to recommend that the FDA approve Benlysta (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus. Although the FDA is not required to follow the recommendations of its advisory committees, it often does so.

In spite of the favourable final vote, many advisory committee members expressed concern during the meeting about a lack of robustness in the drug's efficacy, particularly in African-American patients, who are disproportionately affected by the disease.

"The label will likely have noticeable restrictions, and thin efficacy is already drawing a mixed reception from rheumatologists,” Citi biotech analyst Yaron Werber said in a research note issued following the advisory committee meeting. "We are concerned about the long-term sales potential given (1) modest benefit, (2) poorer activity in US patients than we originally expected, and (3) now more restricted label," the research note states. The analyst cut his annual sales estimates for the drug from $2.6bn to $1.6bn.

The advisory committee members' conclusion that the drug deserves approval but is not necessarily a major advance in treatment was in line with the stance taken by the FDA's internal reviewers in briefing documents prepared in advance of the committee meeting.

The internal reviewers' assessment was generally positive but raised questions about whether the drug's efficacy is sufficient to offset the risks it may pose of suicide, infection and cancer.

Benlysta, which was developed by HGS, inhibits the production of antibodies that attack healthy cells in lupus patients. It met its primary endpoints in two phase III trials. However, the FDA staff reviewers said in their report that "the robustness and the clinical meaning of the findings warrant discussion," noting that one key concern is the drug's failure to demonstrate efficacy in black patients, which is particularly pertinent because the disease is three times as common in black women as in white women.

If it is approved, Benlysta will be the first new treatment for the potentially fatal disease to hit the market since 1958.

17th November 2010


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